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FDA Clears Biotronik Implantable Defibrillator
17 April 2015 - The Food and Drug Administration has approved US-based medical device maker Biotronik's implantable cardioverter defibrillator, the company said on Friday.

Also included in the approval response from the FDA is the latest generation of defibrillator devices for patients with complex heart rhythm conditions.

Two additional options of this unique defibrillator hybrid, the next generation Biotronik DX systems, are now available to US patients. They are:

According to Biotronik, Inventra DX the only such ICD system that can deliver ultra-high energy on the first shock; offering better protection to patients that depend on this life-saving therapy.

Itrevia DX a less invasive therapy with an algorithm that can identify successful pain-free therapies for each patient and dynamically re-apply them as needed.

The complete Itrevia family - including Itrevia VR-T, Itrevia DR-T, and Itrevia HF-T were approved together.

DX technology is based on more than a decade of engineering refinement to ensure accurate and reliable sensing and processing of the atrial signal.

Due to its unique technology, the DX System has continued to drive Biotronik's US customer adoption since it was initially introduced in February 2013.

It is the first defibrillator system equipped to provide dual-chamber diagnostic information with just one specialized defibrillator lead.
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